|
1
|
|
Guidance for industry
|
|
|
Axe Federal Documents Online:Available
|
|
1995
|
Axe Federal Documents Online:Available
|
|
1987
|
Axe Federal Documents Online:Available
|
|
1990
|
Axe Federal Documents Online:Available
|
|
1987
|
Axe Federal Documents Online:Available
|
|
1990
|
2
|
|
Guidance for industry and clinical investigators [electronic resource] : the use of clinical holds f
|
|
|
Axe Federal Documents Online:Available
|
|
2004
|
3
|
|
Guidance for industry and FDA [electronic resource] : current good manufacturing practice for combin
|
|
|
Axe Federal Documents Online:Available
|
|
2004
|
4
|
|
Guidance for industry and FDA review staff [electronic resource] : collection of platelets by automa
|
|
|
Axe Federal Documents Online:Available
|
|
2007
|
5
|
|
Guidance for industry and FDA staff
|
|
|
Axe Federal Documents Online:Available
|
|
2007
|
Axe Federal Documents Online:Available
|
|
2008
|
Axe Federal Documents Online:Available
|
|
2004
|
Axe Federal Documents Online:Available
|
|
2010
|
8 additional entries
|
|
|
6
|
|
Guidance for industry and FDA staff [electronic resource] : application user fees for combination pr
|
|
|
Axe Federal Documents Online:Available
|
|
2005
|
7
|
|
Guidance for industry and FDA staff [electronic resource] : class II special controls guidance docum
|
|
|
Axe Federal Documents Online:Available
|
|
2007
|
8
|
|
Guidance for industry and FDA staff [electronic resource] : commercially distributed analyte specifi
|
|
|
Axe Federal Documents Online:Available
|
|
2007
|
9
|
|
Guidance for industry and FDA staff [electronic resource] : devices used to process human cells, tis
|
|
|
Axe Federal Documents Online:Available
|
|
2007
|
10
|
|
Guidance for industry and FDA staff [electronic resource] : early development considerations for inn
|
|
|
Axe Federal Documents Online:Available
|
|
2006
|
11
|
|
Guidance for industry and FDA staff [electronic resource] : expedited review of premarket submission
|
|
|
Axe Federal Documents Online:Available
|
|
2008
|
12
|
|
Guidance for industry and FDA staff [electronic resource] : how to write a request for designation (
|
|
|
Axe Federal Documents Online:Available
|
|
2005
|
13
|
|
Guidance for industry and FDA staff [electronic resource] : interactive review for medical device su
|
|
|
Axe Federal Documents Online:Available
|
|
2008
|
14
|
|
Guidance for industry and for FDA staff [electronic resource] : enforcement priorities for single-us
|
|
|
Axe Federal Documents Online:Available
|
|
2000
|
15
|
|
Guidance for industry and review staff [electronic resource] : labeling for human prescription drug
|
|
|
Axe Federal Documents Online:Available
|
|
2009
|
16
|
|
Guidance for industry and review staff [electronic resource] : nonclinical safety evaluation of refo
|
|
|
Axe Federal Documents Online:Available
|
|
2008
|
17
|
|
Guidance for industry and review staff [electronic resource] : recommended approaches to integration
|
|
|
Axe Federal Documents Online:Available
|
|
2006
|
18
|
|
Guidance for industry and staff [electronic resource] : minimal manipulation of structural tissue ju
|
|
|
Axe Federal Documents Online:Available
|
|
2006
|
19
|
|
Guidance for industry and staff [electronic resource] : resolution of disputes concerning payment or
|
|
|
Axe Federal Documents Online:Available
|
|
2004
|
20
|
|
Guidance for industry : complementary and alternative medicine products and their regulation by the
|
|
|
Axe Federal Documents Online:Available
|
|
2006
|
21
|
|
Guidance for industry, dairy farms, bulk milk transporters, bulk milk transfer stations and fluid mi
|
|
|
Axe Federal Documents Online:Available
|
|
2003
|
22
|
|
Guidance for industry - dosage delivery devices for OTC liquid drug products [electronic resource].
|
|
|
Axe Federal Documents Online:Available
|
|
2011
|
23
|
|
Guidance for industry - dosage delivery devices for over the counter liquid drug products
|
|
|
Axe Federal Documents Online:Available
|
|
2011
|
24
|
|
Guidance for industry [electronic resource].
|
|
|
Axe Federal Documents Online:Available
|
|
2002
|
25
|
|
Guidance for industry [electronic resource] : 21 CFR, part 11, electronic records : electronic signa
|
|
|
Axe Federal Documents Online:Available
|
|
2002
|
26
|
|
Guidance for industry [electronic resource] : 21 CFR part 11, electronic records, electronic signatu
|
|
|
Axe Federal Documents Online:Available
|
|
2001
|
27
|
|
Guidance for industry [electronic resource] : 180-day exclusivity when multiple ANDAs are submitted
|
|
|
Axe Federal Documents Online:Available
|
|
2003
|
28
|
|
Guidance for industry [electronic resource] : 180-day generic drug exclusivity under the Hatch-Waxma
|
|
|
Axe Federal Documents Online:Available
|
|
1998
|
29
|
|
Guidance for industry [electronic resource] : acceptance of foreign clinical studies
|
|
|
Axe Federal Documents Online:Available
|
|
2001
|
30
|
|
Guidance for industry [electronic resource] : acute bacterial otitis media, developing drugs for tre
|
|
|
Axe Federal Documents Online:Available
|
|
2008
|
31
|
|
Guidance for industry [electronic resource] : acute bacterial sinusitis, developing drugs for treatm
|
|
|
Axe Federal Documents Online:Available
|
|
2007
|
32
|
|
Guidance for industry [electronic resource] : addendum to E2C clinical safety data management : per
|
|
|
Axe Federal Documents Online:Available
|
|
2004
|
33
|
|
Guidance for industry [electronic resource] : adequate and appropriate donor screening for hepatitis
|
|
|
Axe Federal Documents Online:Available
|
|
2007
|
34
|
|
Guidance for industry [electronic resource] : adverse reactions section of labeling for human prescr
|
|
|
Axe Federal Documents Online:Available
|
|
2006
|
35
|
|
Guidance for industry [electronic resource] : advisory committee meetings : preparation and public a
|
|
|
Axe Federal Documents Online:Available
|
|
2008
|
36
|
|
Guidance for industry [electronic resource] : advisory committees : implementing Section 120 of the
|
|
|
Axe Federal Documents Online:Available
|
|
1998
|
37
|
|
Guidance for industry [electronic resource] : aerosol steroid product safety information in prescrip
|
|
|
Axe Federal Documents Online:Available
|
|
1997
|
38
|
|
Guidance for industry [electronic resource] : alternate source of the active pharmaceutical ingredie
|
|
|
Axe Federal Documents Online:Available
|
|
2000
|
39
|
|
Guidance for industry [electronic resource] : amendment (donor deferral for transfusion in France si
|
|
|
Axe Federal Documents Online:Available
|
|
2006
|
40
|
|
Guidance for industry [electronic resource] : an acceptable circular of information for the use of h
|
|
|
Axe Federal Documents Online:Available
|
|
2003
|
41
|
|
Guidance for industry [electronic resource] : ANDAs, impurities in drug products.
|
|
|
Axe Federal Documents Online:Available
|
|
2005
|
42
|
|
Guidance for industry [electronic resource] : ANDAs, impurities in drug substances.
|
|
|
Axe Federal Documents Online:Available
|
|
2009
|
43
|
|
Guidance for industry [electronic resource] : ANDAs, pharmaceutical solid polymorphism, chemistry, m
|
|
|
Axe Federal Documents Online:Available
|
|
2007
|
44
|
|
Guidance for industry [electronic resource] : animal models : essential elements to address efficacy
|
|
|
Axe Federal Documents Online:Available
|
|
2009
|
45
|
|
Guidance for industry [electronic resource] : antiviral product development, conducting and submitti
|
|
|
Axe Federal Documents Online:Available
|
|
2006
|
46
|
|
Guidance for industry [electronic resource] : assessing donor suitability and blood and blood produc
|
|
|
Axe Federal Documents Online:Available
|
|
2005
|
47
|
|
Guidance for industry [electronic resource] : availability of licensed donor screening tests labeled
|
|
|
Axe Federal Documents Online:Available
|
|
2000
|
48
|
|
Guidance for industry [electronic resource] : available therapy.
|
|
|
Axe Federal Documents Online:Available
|
|
2004
|
49
|
|
Guidance for industry [electronic resource] : bar code label requirements, questions and answers.
|
|
|
Axe Federal Documents Online:Available
|
|
2006
|
50
|
|
Guidance for industry [electronic resource] : bioanalytical method validation.
|
|
|
Axe Federal Documents Online:Available
|
|
2001
|
Add Marked to Bag
Add All On Page
|